A Study of Intra-operative Imaging in Women With Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.
Eligibility criteria
Qualifiers
18 years or older
Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
Scheduled to undergo debulking or cytoreductive surgery
Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure
Disqualifiers
Documented history of allergic reaction to ICG
Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection
Did not undergo rectosigmoid resection intraoperatively
Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
Trial design
Treatments tested in this trial
- Intravenous Indocyanine Green/ICG injection
- PINPOINT endoscopic fluorescence imaging system
- Endoscopy
Treatment groups
310 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov